Zinforo 600 mg powder for concentrate for solution for infusion

The Summary of Product Characteristics (SPC or SmPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and method of administration - Tables 2 and 4 updated to include dosage in paediatric patients. Section also updated to include neonates and infants. Statement on paediatric population removed.

New statememnt added; "The recommended dosage of Zinforo shown in Table 2 for paediatric patients < 2 months of age are based on pharmacokinetic-pharmacodynamic modelling and simulation".

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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Section

Change

4.1 Indications

Added indication for children from the age of 2 months

4.2 Posology

Added dosing for children with normal renal function and for children with renal impairment from 2 years.

4.8 Undesirable effects

Added text on the paediatric population

5.2 Pharmacokinetic properties

Revised text on special populations, renal impairment and paediatric population

5.3 Pre-clinical

Added section on juvenile toxicity

10 Date of Revision

1 June 2016

Updated on 1 July 2016 PIL

Reasons for updating

Change to, or new use for medicine

Change to warnings or special precautions for use

Change to date of revision

Change to dosage and administration

Updated on 21 March 2016 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Change to section 4.8 - Undesirable effects

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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4.2 Minor editorial/formatting changes.

4.8 Addition of Agranulocytosis as a rare adverse reaction. Minor formatting changes and change ceftaroline fosamil to Zinforo in the rash section.

10 change to revision date.

Updated on 18 March 2016 PIL

Reasons for updating

Change to side-effects

Change to date of revision

Correction of spelling/typing errors

Updated on 8 December 2015 SmPC

Reasons for updating

Change to section 4.8 - Undesirable effects

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

﻿

-section 4.8 – editorial changes

- section 4.8 – addition of side effect – addition of ‘eosinophilia’ as frequency ‘not known’ side effect in table

-section 10 – updated date of revision

Updated on 7 December 2015 PIL

Reasons for updating

Change to side-effects

Change to date of revision

Updated on 2 October 2015 PIL

Reasons for updating

Addition of information on reporting a side effect.

Updated on 1 October 2015 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.8 - Undesirable effects

Change to Section 4.8 – Undesirable effects - how to report a side effect

Change to section 5.2 - Pharmacokinetic properties

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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-section 4.2 – editorial changes

-section 4.4 – more detail added on dosages correlated with the incidence of DAGT seroconversion in patients receiving ceftaroline fosamil

- section 4.8 - Addition of information on a study in adult patients with cSSTI - most common adverse reactions occurring in ≥ 3% of patients treated with Zinforo were nausea, headache, and rash. The safety profile of Zinforo was similar to that observed in previous pooled Phase III studies with the exception of both a greater incidence of rash in Asian patients and a greater incidence of DAGT seroconversion.